Pharmacokinetics of the addition of an acidic beverage to posaconazole co-administered with a proton pump inhibitor in GVHD patients

Pharmacokinetics of the addition of an acidic beverage to posaconazole co-administered with a proton pump inhibitor in GVHD patients - Pharmokinetics of cola addition to posaconazol and PPI in GVHD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36495

Enrollment

Registered

2011-04-07

Start date

2011-08-12

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

graft versus host ziekte graft versus host ziekte

Interventions

200mL of an acidic beverage (Coca Cola) will be administered concomitantly with posaconazole and PPI intake for a period of 7 days until a new steady state has been reached

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: *recipients of hematopoietic stem-cell transplantation (HSCT) with graft versus host disease (GVHD) using PPI *start or use of posaconazole for invasive fungal infection (IFI) prophylaxis with concomitant PPI use for at least twelve days or one week when already using posaconazole

Exclusion criteria

Exclusion criteria: *current clinical significant invasive fungal infection requiring treatment *inability to sign informed consent *inability to take oral medication *allergy to posaconazole, PPI or the acidic beverage *start or discontinuation of a CYP3a4 inhibitor or P-glycoprotein inducer during the study period *age

Design outcomes

Primary

Measure	Time frame
difference in the bioavailability of posaconazole within patients on PPI with or without concomitant use of the acidic beverage in hematopoietic stem-cell transplantation patients with graft versus host disease.	—

Secondary

Measure	Time frame
To investigate whether the plasma concentrations of posaconazole in graft-versus-host-disease (GVHD) patients, adversely affected by the co-administration of proton pump inhibitors (PPIs), can be restored by the acidic beverage. Feasibility of concomitant administration of posaconazole and the acidic beverage in GVHD patients. Plasma pharmacokinetics of posaconazole at the start and at steady-state in graft-versus-host-disease (GVHD) patients concomitantly using PPI.	—

Measure

Time frame

To investigate whether the plasma concentrations of posaconazole in graft-versus-host-disease (GVHD) patients, adversely affected by the co-administration of proton pump inhibitors (PPIs), can be restored by the acidic beverage. Feasibility of concomitant administration of posaconazole and the acidic beverage in GVHD patients. Plasma pharmacokinetics of posaconazole at the start and at steady-state in graft-versus-host-disease (GVHD) patients concomitantly using PPI.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)